The present invention generally relates to graphical user interface (GUI) displayable on a medical device or instrument such as a programmer to provide a visual/animated display of patient organs including pictorial representation of implanted medical devices (IMDs) in a patient. Specifically, the invention relates to a communication means with the IMDs in a patient on a real time basis to evaluate, monitor and dispense therapy and clinical care as needed. Preferably, an interface medical instrument such as a programmer is used to display information relating to the IMDs including operating parameters and status. The system further enables remote transfer of information and communication between instruments at the patient""s station or home and caregivers at different locations. using web-enabled network systems such as the Internet.
The present invention is compatible and complementary with the elements disclosed in the following pending applications: xe2x80x9cMedical System Having Improved Telemetry,xe2x80x9d filed Jul. 19, 1999, Ser. No. 09/356,340; xe2x80x9cSystem and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location,xe2x80x9d filed on Jul. 21, 1999, Ser. No. 09/358,081; xe2x80x9cApparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,xe2x80x9d filed on Oct. 26, 1999, Ser. No. 09/426,741; xe2x80x9cTactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,708; xe2x80x9cApparatus and Method for Automated Invoicing of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429; xe2x80x9cApparatus and Method for Remote Self-Identification of Components in Medical Device Systems,xe2x80x9d filed Oct. 29, 1 999, Ser. No. 09/429,956; xe2x80x9cApparatus and Method to Automate Remote Software Updates of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,960; xe2x80x9cMethod and Apparatus to Secure Data Transfer From Medical Device Systems,xe2x80x9d filed Nov. 2, 1999, Ser. No. 09/431,881 xe2x80x9cImplantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,xe2x80x9d filed Nov. 4, 1999, Ser. No. 09/433,477; xe2x80x9cRemote Delivery Of SoftwareBased Training For Implantable Medical Device Systems,xe2x80x9d filed Nov. 10, 1999, Ser. No. 09/437,615; xe2x80x9cApparatus and Method for Remote Therapy and Diagnosis in Medical Devices Via Interface Systems,xe2x80x9d filed Dec. 14, 1999, Ser. No. 09/460,580; xe2x80x9cVirtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systemsxe2x80x9d filed Dec. 17, 1999, Ser. No. 09/466,284; xe2x80x9cInstrumentation and Software for Remote Monitoring and Programming of Implantable Medical Devices (IMDs), filed Dec. 21, 1999, Ser. No. 60/172,937; xe2x80x9cApplication Proxy For Telecommunication-enabled Remote Medical Access Instruments,xe2x80x9d filed Dec. 23, 1999, Ser. No. 60/173,081; xe2x80x9cInformation Network Scheme For Interrogation Of Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,064; xe2x80x9cMedical Device GUI For Cardiac Electrophysiology Display And Data Communications,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,065; xe2x80x9cIntegrated Software System For Implantable Medical Device Installation And Management,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,082; xe2x80x9cDynamic Bandwidth Monitor And Adjuster For Remote Communications With A Medical Device,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,083 xe2x80x9cLarge-Scale Processing Loop For Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,079; xe2x80x9cChronic Real-Time Information Management Systems For Implantable Medical Devices (IMDs),xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,062; xe2x80x9cAutomatic Voice and Data Recognition For Medical Device Instrument Systems,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,071 xe2x80x9cCentral Switchboard to Facilitate Remote Collaboration With Medical Instruments,xe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,080; which are all incorporated by reference herein in their entireties.
A technology based health care system that fully integrates the technical and social aspects of patient care and therapy should be able to flawlessly connect the client with care providers, irrespective of separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted modern medical practice, development in communications technology are making it evermore possible to provide medical services in a time and place in an independent manner.
Prior art methods of clinical services are generally limited to in-hospital operations. For example, if a physician needs to review the performance parameters of an implantable medical device in a patient, it is likely that the patient has to go to the clinic. Further, if the medical conditions of a patient with an implantable medical device warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems. Under the exemplary scenario, as a segment of the population with implanted medical devices increases, many more hospitals/clinics, including service personnel, will be needed to provide in-hospital service for the patients, thus escalating the cost of health care. Additionally, the patients will be restricted and inconvenienced by the need to either stay in the hospital or make very frequent visits to a clinic.
Yet another condition of the prior art practice requires that a patient visit a clinic center for occasional retrieval of data from the implanted medical device to assist the operation of the device and gather patient history for both clinical and research purposes. Such data is acquired by having the patient in a hospital/clinic to upload the stored data from the implantable medical device. Depending on the frequency of data collection, this procedure may pose serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed. Further, in medical practice, it is an industry-wide standard to keep an accurate record of past and contemporaneous procedures relating to an implantable medical device uplink with, for example, a programmer. It is required that the report contain identification of all the medical devices and instruments involved in any interactive procedure. Specifically, all peripheral and major devices and instruments that are used in downlinking to the IMD, need to be reported.
IMDs, medical instruments, programmers and related medical devices are distributed throughout the world. Further, the number of people with implanted medical devices has been increasing steadily over the last few years. Thus, it is desireable to have a high efficiency communication system that would provide display and data communications with medical devices. A further limitation of the prior art relates to the management of multiple implanted medical devices in a single patient. Advances in modern therapy and treatment have made it possible to implant a number of devices in a patient. For example, IMDs such as a defibrillator or a pacer, a neural implant, a drug pump, a physiology monitor, and various other IMDs may be implanted in a single patient. To successfully manage the operations and assist the performance of each device in a patient with multi implants requires continuous updates and monitoring of the devices. Further, it may be preferred to have an operable communication between the various implants to provide a coordinated clinical therapy to the patient. Thus, there is a need to monitor the IMDs, including the programmer and instruments, on a regular if not continuous basis, to ensure optimal patient care. In the absence of other alternatives, this imposes a great burden on the patient if a hospital or clinic is the only center where the necessary follow-up and data communications could be made to enable upgrade evaluation and digestment of the IMDs. Further, even if feasible, the situation would require the establishment of multiple service areas or clinic centers to support the burgeoning number of multi-implant patients worldwide.
Accordingly, it is vital to have a user interface device or instrument that would enable remote communications and display of implanted medical device data. Specifically, it would be desireable to connect to a remote expert data center, a remote wavebase data center, or a remote data centerxe2x80x94all these terms are alternate equivalents of each other as used herein. The ability to transfer information between the IMDs and the remote center is highly desirable in order to dispense therapy and clinical care on real time basis.
PCT Publication WO00/30712 to Nova, Richard C. et al, discloses a visual and aural user interface for an automated external defibrillator (AED) designed for use by a rescuer, with minimal or no training, during a medical emergency. The AED implements a user interface program which guides the rescuer through operation of the AED and application of CPR and defibrillation therapy to a patient by displaying a series of visual instructions on a graphic display or other visual output device. The system also provides additional aural instructions via a speaker or other aural output device. The rescuer merely needs to press a start button to initiate operation of the AED and begin CPR and defibrillation instructions.
U.S. Pat. No. 5,447,164 to Shaya et al, discloses an interactive medical information display system and method for displaying user definable patient events. Specifically, the invention discloses an interactive medical information display system that includes a mechanism for acquiring physiological parameters from a patient and the mechanism for storing the parameters in a real time data base. In addition, the system includes a mechanism for users to define event types in an event definition language, and a mechanism for users to modify existing event types. Users may select a set of event types for display and an event generator accesses the data base to monitor the physiological parameters in order to detect event occurrences as defined by the event types. A display mechanism displays the event occurrences and provides users with the ability to select event occurrences randomly or sequentially. Upon selection, other information is displayed.
U.S. Pat. No. 4,958,632 to Duggan discloses an adaptable digital computer controlled cardiac pacemaker. The invention discloses a multi-mode adaptable, implantable pacemaker, including a microprocessor and memory programmed or capable of being programmed with a variety of processes for stimulating the patient""s heart and/or for sensing and transmitting to a device external of the patient""s body. Specifically, various conditions or activities of the patient""s heart or conditions of the implanted medical device are sensed or transmitted to the external device. The pacemaker is capable of transmitting these signals via link such as RF or acoustical link to an external monitoring apparatus. The external apparatus may transmit code signals to be received by the pacemaker whereby the pacemaker""s memory may be reprogrammed dependent upon change of the patient""s condition.
U.S. Pat. No. 4,142,533 to Brownlee et al, discloses a monitoring system for cardiac pacers. The invention describes a system for telemetering and monitoring the functions of an implanted pacemaker as well as controlling the testing of the functions from a remotely located central facility. The invention claims capabilities of directly and simultaneously transmitting from the pacer electrical signals indicative of multiple pacer functions such as pacer rate, cell voltage, refractory period, heart rate, pacer inhibited R-Wave level and sensing margin, sensing circuits and other component failure, cardiac electrode lead break and hermetic integrity. The indicator signals are picked up at the patient""s location for local analysis and/or for telephonic communication to a remote central monitoring station. The central station may control testing of the pacemaker functions by transmitting command signals back telephonically for coupling through cooperating external and implanted inductances or magnetically controlled switches to the implanted pacer circuitry.
U.S. Pat. No. 4,527,567 to Fischler et al describes a method and apparatus for automatically evaluating the quality of the performance of a cardiac pacing system. Specifically the invention discloses an extracorporeal self-contained online beat to beat pacemaker function analyzer for automatically evaluating and indicating the quality of performance of cardiac pacing systems implanted in place for routine examination of ambulatory patients. Further, long term surveillance of hospitalized patients and examination of ECG traces of remote technical patients transferred by telephone or radio to central follow-up stations is also disclosed. The pacemaker function analyzer provides a comprehensive examination of a synchronous demand and demand hysterisis testmakers of all makes including the state of the pacemaker""s battery, the intactness of the electronic circuitry and of the electrodes and of the proper location of the electrodes in the heart.
U.S. Pat. No. 4,596,255 to Snell et al, discloses apparatus for interpreting and displaying cardiac events of a heart connected to a cardiac pacing means. The system includes a display unit, a telemetry head, a first interpreting means connected to the telemetry head, a second interpreting means connected to a number of ECG electrodes having paddles at said digital end by electrical conduits, a control means connected to the first and second interpreting means and respectively, a multi-section memory means with means connected to said control means. Further, a digital to analog converter connected to a memory system, a printing means and a logic system that is in turn connected to the display means. U.S. Pat. No. 4,791,936 to Snell et al, discloses, in addition to the disclosures in U.S. Pat. No. 4,596,255, a process in which information telemetered from the implanted pacing means is separated in viable sets of data pertaining to a prescribed function such as atrial events, ventricular events, pacemaker timed events, sensor events and the like. Skin ECG information may also be received through another interpreting means in addition to pacemaker telemetered data. Parallel processing channels are employed to process all the received data while maintaining synchronization therebetween. Memory means allows the processed data to be stored for subsequent printouts through a digital to analog converter and printer or to be displayed on a display monitor. The display monitor is controlled by display logics that includes the capability to simultaneously display a number of selected data sets while maintaining the synchronization therebetween. The system also allows displayed events to be identified with unique markers, or synchronized with displayed time intervals associated with the operation of the pacemaker.
U.S. Pat. No. 4,809,697 to Causey, III et al discloses interactive programming and diagnostic system for use with implantable pacemakers. The invention describes an analyzer programmer system for use with an implantable medical device. The system is claimed to facilitate non-invasive communications with the implanted device to make analysis of the operation of the implanted device easier to understand and perform. Further conventional processor means is used for processing a sequence of stored instructions. Programmed intervals to be sent to the implantable device are displayed by the system in tabular form, or as skilled time lines or bars, with each separate interval beginning and ending in proper time sequence, thereby providing a prediction of the expected performance. The system also includes telemetry head means for sending and receiving control and data signals to and from the implanted medical device. The telemetry head includes processing circuitry claimed to simplify the other circuitry needed in order to effectuate such communication.
U.S. Pat. No. 5,713,937 to Nappholz et al, discloses a pacemaker programmer menu with selectable real or simulated implant data graphics. The invention discloses a graphic user interface for a cardiac implant such as an implant programmer which includes image generators for generating multiple images on the screen. Each image responding to a presentation of a parameter related to the operation of the implant or a cardiac function and an indicia generator for superimposing on the images indicative of the interrelation between the parameters. The indicia allows the user to obtain a clear understanding and appreciation of the cause and effect rules between various cardiac parameters and/or functions. The parameters or functions could be actual, that is obtained from the implanted or the patient heart or they can be simulated to provide the user an indication of how the pacemaker will operate under these simulated conditions parameters.
U.S. Pat. No. 5,724,985 to Snell et al, discloses a user interface for an implantable medical device using an integrated digitizer display screen. The invention relates to an apparatus and method for improved interface for communicating with implanted medical devices. An integrated digitizer display screen and an digitizer pen serve as a primary input to this device to a tablet computer adapted to receive real time and stored medical data. The pen is used to select programming options by tapping portions of the digitizer based on visual images on the display. Additionally, the pen may be used to manipulate the medical data through the use of gestures or be used to enter free form annotations concerning the medical data. An additional aspect of the invention includes a user interface for use of a questionnaire card to input information into the tablet computer by tapping the pen on the marked answers on the questionnaire card.
U.S. Pat. No. 5,372,607 to Stone et al, discloses a method and apparatus for monitoring pacemaker intervals. In accordance with the invention, a pacemaker is provided which is capable of obtaining and storing information about a patient""s cardiac function, and about a pacemaker""s operation during a brief exercise interval. The data collected includes information about the number of cardiac events during each two second interval of the exercise as well as a percentage of paced events during each two second interval. In this manner, data reflecting output of the pacemaker activity is collected. The invention is operable in conjunction with an external programming/processing unit that receives the stored data after the exercise test is concluded. The data is processed and presented on the programmer""s screen in a manner that enables the clinician to readily assimilate and observe the effects of hypothetical changes in retrosponse programming in the pacemaker. Additionally, the clinician is able to observe the program""s AV rated adaptation profiles in conduction with the patient""s actual AV performance, and compares this data with an AV profile from a typical healthy heart.
U.S. Pat. No. 5,716,324 to Snell, describes a method and system for organizing, viewing and manipulating information in implantable device programmers. In accordance with this invention, a method and system are provided for organizing, viewing and manipulating information in an implantable device programmer. The information includes programmable parameters which are divided into key parameters in subordinate parameters. Each key parameters has one or more associated subordinate parameters that are displayed when the user selects the key parameter. These parameters are not displayed when a different key parameter is selected. Subordinate parameters can be made sticky by the user. A sticky subordinate parameter is displayed regardless of whether or not the user has selected its associated key parameter. Certain parameters are linked so that when the user selects any one of the linked parameters, all linked parameters are displayed. Certain parameters are designated as inactive because of interactions with other parameters.
U.S. Pat. No. 5,722,999 to Snell, discloses a system and method for storing and displaying historical medical data measured by an implantable medical device. The invention relates to a system invented for acquiring medical data integrating recently acquired medical data with previously acquired medical data, storing the integrated medical data and displaying the integrated medical data to a medical practitioner in a convenient format. The recently acquired medical data are integrated with historical medical data in an implantable medical device programmer. The data may be initially displayed in graphical and text formats during a patient""s follow-up visit. The historical medical data may be stored in the programmer or the implantable medical device or both. Medical data may include physiological data pertaining to the patient""s medical condition, parametric data pertaining to the operational characteristics of the implanted medical device, identification data including patient""s background information and comments, including the medical practitioner""s comments.
U.S. Pat. No. 5,833,623 to Mann et al, relates to a system and method for facilitating rapid retrieval and evaluation of diagnostic data stored by an implantable medical device. The invention relates to an implantable medical device programmer that includes a variety of features for allowing the clinician to perform an automated and customized follow-up examination of a patient having an implanted cardiac implantable device. A custom protocol feature of the programmer allows the clinician to prespecify and then semi-automatically follow an ordered sequence of protocol steps. Each protocol step preferably involves the interrogation of the implanted medical device in the display by the programmer of associated implantable device data, such as for example, heart rate histogram or the results of a ventricular capture test. When the clinician initiates a custom protocol, the programmer automatically retrieves all of the diagnostic data records of the protocol in the protocol order. This automatic retrieval is performed in the background allowing the clinician to begin viewing the initial diagnostic data records of the protocol while the other items are being retrieved.
U.S. Pat. No. 5,421,830 to Epstein et al, describes a programming system having means for recording and analyzing a patient""s cardiac signal. Specifically, the invention relates to a programming system that allows a physician or medical personnel to optimize the settings of various arrhythmia detection criteria and/or parameters related to hemodynamic performance to be programmed into the implanted cardiac stimulating device. The programming system may play back the recorded signals to test the detection criteria and hemodynamic performance and may simulate the response of the device to the cardiac signal. Alternatively, the programming system may relay back an artificially created or previously stored cardiac signal for test purposes. As a result, the recorded signal may be played back repeatedly without unnecessarily stressing the patient""s heart. Additionally, the programmer may suggest a specific arrhythmia detection criteria and therapies to a physician based on an analysis of a patient""s arrhythmia.
U.S. Pat. No. 5,843,148 to Evers et al, discloses a pacemaker system with enhanced programmable modification capacity. Specifically, the invention relates to a pacemaker system that provides flexibility in reprogramming of the control software or a program which is controlling an implanted pacemaker. The system includes an external programmer device that is capable both of programming the implanted device in a conventional way and also downloading new control software to the implatned device. In applications where there are more than one pacemakers, the invention enables identifying the type of pacemaker within the group and a set of permissions data representative of different types within the group to which it is permitted to be programmed. Upon interrogating the implanted device, the programmer determines whether the device is part of the system, what it""s group and type is, and whether it is able to modify the device.
U.S. Pat. No. 5,891,178 to Mann et al, describes a program or system and associated methods for rapidly evaluating and programming an implanted cardiac device. Specifically, the invention relates to an improved pacemaker programmer and diagnostic system for retrieving information stored within a pacemaker to be analyzed in real time. The information stored in the pacemaker is retrieved by means of a telemetric communication link. The system automatically identifies significant patient events such as regions of increased heart rate or loss of atrial or ventricular capture. In display, significant events are automatically identified so that the monitoring physician need not scroll through the retrieved data to identify significant events. Further, the system automatically suggests modifications to pacemaker parameters based upon certain retrieved data. The physician need only confirm the changes in order to modify the parameters within the pacemaker so that the modification of Smaker parameters is reduced to a one step process. The system also includes features for allowing the physician to interactively adjust program parameters while viewing those parameter changes in real time.
PCT publication WO00/38575 to Miesel et al discloses a non-invasive cardiac monitoring system and method with communications interface. Specifically, the invention relates to a system and method for determining a patient""s cardiac output in a non-invasive manner and transmitting cardiac output data to remote host processor, communication system or a local output device. The system utilizes an implanted medical device coupled to an oxygen sensor, the oxygen sensor provides venous oxygen saturation data to the implantable medical device. The oxygen consumption unit produces oxygen consumption data using air exhaled by a patient. A processing unit calculates a cardiac output result in real time using the venous oxygen saturation data, the oxygen consumption data and arterial oxygen saturation data assumed to be about 100% or acquired using a sensor external to the patient. The interface may include a modem, a computer interface, a network interface or communication system interface, for example. The processing unit may communicate the cardiac output result to the remote host processor in an analog, digital or optical form.
U.S. Pat. No. 6,088,618 to Kerver discloses a pacemaker system and method for providing manual display concurrent with pacemaker software modification. The invention relates to a programmable pacemaker who is a programmer that has the capability of making software control modifications to one or more of pacemaker types that can be software modified to different control functions. The program queries manual data relating to the manual corresponding to each pacemaker type. Whenever a new control software release is loaded into the programmer, an accompanying new manual portion is also loaded into programmer memory. The programmer can then determine what manual portion or portions are superseded in the new control software is downloaded into any one of the respective different test maker types of the family.
A further limitation of the prior art relates to the management of multiple medical devices in a single patient. As indicated hereinabove, advances in modern patient therapy and treatment have made it possible to implant a number of devices in a patient. For example, an IMD such as a defibrillator, a neural implant, a drug pump, a separate physiologic monitor, and various other IMDs may be implanted in a single patient. To successfully manage the operations and assess the performance of each device in a patient with multiple implants, require continuous updates and monitoring of the devices. Further, it may be preferred to have an operable communication between the various implants to provide a coordinated clinical therapy to the patients.
Thus, there is a need to monitor the IMDs including a programmer on a regular, if not continuous, basis to ensure optimal patient care. In this regard, a graphical user interface (GUI) that integrates various static and animated images of the heart, and the implantable medical device would provide significant advances over the prior art. Specifically, by using enabling software in conjunction with a graphical user interface transfer of medical and device information to remote sites via the Internet, Intranet, Extranet, World Wide Web or other medium, monitoring and management of chronic patients could be enhanced. More specifically, using an instrument that may be placed in a patient""s home the GUI of the present invention in combination with enabling software, could provide global connection and communication between patients and healthcare providers to monitor and manage the implantable devices remotely on a continuous basis.
The present invention discloses a GUI to illustrate various images and data. The GUI and associated software enable interactivity via a menu bar and/or a pointer pen. Pointing by the pen to a relative part of the GUI opens further menus. Yet another aspect of the invention includes a GUI implemented by integrating softwares to provide additional features into an instrument such as a programmer. Specifically, features relating to point interrogation and quick look screen displays to provide users menus that would enable them to view illustrations and images of the heart, the implantable medical device, and various other parameters. An additional aspect of the invention includes the use of a highly diverse software network system incorporated with the GUI to transport information to a patient station, remote station and expert stations such as a clinical care provider using a dedicated software. The implementation may preferably use Jini as a way to make applets move transparently across networks regardless of the type of connection deployed.
Yet another aspect of the invention relates to implementation of various communication systems to transfer the GUI illustrations to remote stations on a real time basis. For example, ECG analysis relating to exact heart rhythm, visualization and animation may be transmitted to a remote location via the internet, intranet, extranet or other equivalent medium, for remote viewing by physicians and caregivers.
The invention enables remote chronic management of one or more devices implanted in one or more patients by providing critical images for purposes of review and evaluation on a continuous basis.